FDA publishes a guidance on how to present more consumer-friendly efficacy and risk information in direct-to-consumer promotional labeling and ads.
Two Oncology Center of Excellence executives describe the benefits of the new QCARD initiative intended to improve study proposals that use real-world...
Senate majority leader Chuck Schumer says FDA must develop a plan to deal with drug shortages and Congress must pursue a legislative solution to the p...
FDA publishes a draft guidance about the prohibition on wholesaling of compounded drugs under Section 503B of the Federal Food, Drug, and Cosmetic Act...
FDA issues a complete response letter on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye drug for treating pati...
FDA approves a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis in certain adult patients.
The U.S. government arrests former DePuy Synthes sales representative Matthew Capobianco on eight counts of wire fraud and one count of making false s...
FDA announces additional changes in the way the Office of Regulatory Affairs operates.
